BEUDAMED
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    OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID

    FDA 510(k)
    FDA Class 1 ·Radiology

    REPROCESSED DISPOSABLE TROCARS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SIMPLE PREP CARBIDE

    FDA Adverse Event
    Injury ·COLTENE WHALEDENT INC.·Product code EJL·February 3, 2022

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·January 14, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·November 19, 2010

    HOMECHOICE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 3, 2014

    PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080361. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014